FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
70518-1035
11-digit product format
705181035
Labeler code
70518
Product ID
70518-1035_5100773e-8dcc-aced-e063-6294a90a3c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091368
Marketing category
ANDA
Marketing start
2018-02-27
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1035-0clonidine hydrochloride30 in 1 BLISTER PACKTABLET3014
70518-1035-1clonidine hydrochloride180 in 1 BOTTLE, PLASTICTABLET18014
70518-1035-2clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET9014
70518-1035-3clonidine hydrochloride30 in 1 BLISTER PACKTABLET3014
70518-1035-4clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET3014
70518-1035-5clonidine hydrochloride90 in 1 BOTTLE, PLASTICTABLET9014
70518-1035-6clonidine hydrochloride180 in 1 BOTTLE, PLASTICTABLET18014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1035CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 7 package rows20250504_574640a5-829d-4e9d-be32-832a48cbd8dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN574640a5-829d-4e9d-be32-832a48cbd8dd14
884173clonidine hydrochloride 0.1 MG Oral TabletSCD574640a5-829d-4e9d-be32-832a48cbd8dd14
884173clonidine HCl 100 MCG Oral TabletSY574640a5-829d-4e9d-be32-832a48cbd8dd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1035-07051810350030 in 1 BLISTER PACKHistorical
70518-1035-170518103501180 in 1 BOTTLE, PLASTICHistorical
70518-1035-27051810350290 in 1 BOTTLE, PLASTICHistorical
70518-1035-37051810350330 in 1 BLISTER PACKHistorical
70518-1035-47051810350430 in 1 BOTTLE, PLASTICHistorical
70518-1035-57051810350590 TABLET in 1 BOTTLE, PLASTIC (70518-1035-5) 90 tablet2025-07-01NoNoCurrent
70518-1035-670518103506180 TABLET in 1 BOTTLE, PLASTIC (70518-1035-6) 180 tablet2025-07-01NoNoCurrent